Tag: FDA generic drugs

Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence

Bioequivalence ensures generic drugs work just like brand-name versions. The FDA requires proof that both deliver the same amount of active ingredient into the bloodstream at the same rate, using strict statistical standards.

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Dissolution Testing: How the FDA Ensures Generic Drug Quality

Dissolution testing is how the FDA ensures generic drugs release their active ingredients at the same rate as brand-name versions, proving bioequivalence without human trials. It's a precise, science-backed process that keeps generics safe and affordable.

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